Complete Response Letter For Outlook’s Bevacizumab Is Both Straightforward And Elusive

Low On Cash, Rush Is On To Clarify US FDA’s Concerns

Paralleling the challenges of the wet AMD market it hopes to enter, the CRL for Lytenava cites manufacturing issues, which Outlook Therapeutics feels it can easily address, as well as the need for confirmatory clinical evidence, which has left the firm scrambling for a meeting with FDA.

Close up cropped shot, face of senior woman eye looking straight, into distance.
Outlook will request at Type A meeting with the FDA to discuss the CRL • Source: Shutterstock

More from Complete Response Letters

More from Product Reviews